Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80317

15 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 07, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
SPS Sterilization, Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

15 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 15

Edwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized.

Z-3027-2018
Recall number
Z-3027-2018
Initiated
March 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
SPS Sterilization, Inc
Quantity
10 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

Code information

Code Number AAO24TFA-R; Lot Number 59736014; Serial Numbers 16504192017-01, 16504192017-02, 16504192017-03, 16504192017-04, 16504192017-05, 16504192017-06, 16504192017-07, 16504192017-08, 16504192017-09, 16504192017-10

Distribution pattern

US distribution to AZ, CA, FL, OH, PA, TX, VA, WV

device · product 2 of 15

Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized.

Z-3028-2018
Recall number
Z-3028-2018
Initiated
March 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
SPS Sterilization, Inc
Quantity
6 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

Code information

Code Number EZC24A-R; Lot Number 59634962; Serial Numbers 16401032017-01, 16401032017-02, 16401032017-03, 16401032017-04, 16401032017-05, 16401032017-06, 16401032017-07, 16401032017-08, 16401032017-09, 16401032017-10, 16401032017-11, 16401032017-12, 16401032017-13, 16401032017-14, 16401032017-15, 16401032017-16, 16401032017-17, 16401032017-18, 16401032017-19, 16401032017-20, 16401032017-21, 16401032017-22, 16401032017-23, 16401032017-24, 16401032017-25, 16401032017-26, 16401032017-27, 16401032017-28, 16401032017-29, 16401032017-30, 16401032017-31, 16401032017-32, 16401032017-33, 16401032017-34, 16401032017-35, 16401032017-36, 16401032017-37

Distribution pattern

US distribution to AZ, CA, FL, OH, PA, TX, VA, WV

device · product 3 of 15

Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, resterilized.

Z-3029-2018
Recall number
Z-3029-2018
Initiated
March 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
SPS Sterilization, Inc
Quantity
10 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

Code information

Code Number TF038L-R; Lot Number 59634935; Serial Numbers 18302172017-01, 18302172017-02, 18302172017-03, 18302172017-04, 18302172017-05, 18302172017-06, 18302172017-07, 18302172017-08, 18302172017-09, 18302172017-10

Distribution pattern

US distribution to AZ, CA, FL, OH, PA, TX, VA, WV

device · product 4 of 15

Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), resterilized.

Z-3030-2018
Recall number
Z-3030-2018
Initiated
March 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
SPS Sterilization, Inc
Quantity
5 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

Code information

Code Number TF034L-R; Lot Number 59739865; Serial Numbers 18304192017-12, 18304192017-13, 18304192017-14, 18304192017-15, 18304192017-16

Distribution pattern

US distribution to AZ, CA, FL, OH, PA, TX, VA, WV

device · product 5 of 15

Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.3MM) X 37CM (14.5"), resterilized.

Z-3031-2018
Recall number
Z-3031-2018
Initiated
March 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
SPS Sterilization, Inc
Quantity
5 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

Code information

Code Number TF293702-R; Lot Number 59655659; Serial Numbers 18304192017-02, 18304192017-03, 18304192017-04, 18304192017-05, 18304192017-06

Distribution pattern

US distribution to AZ, CA, FL, OH, PA, TX, VA, WV

device · product 6 of 15

Edwards Lifesciences Femoral Venous Cannula, 18FR, resterilized.

Z-3032-2018
Recall number
Z-3032-2018
Initiated
March 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
SPS Sterilization, Inc
Quantity
1 unit total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

Code information

Code Number VFEM018-R; Lot Number 59740463; Serial Number 16704192017-01

Distribution pattern

US distribution to AZ, CA, FL, OH, PA, TX, VA, WV

device · product 7 of 15

Edwards Lifesciences Femoral Venous Cannula, 20F X 55CM, resterilized.

Z-3033-2018
Recall number
Z-3033-2018
Initiated
March 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
SPS Sterilization, Inc
Quantity
1 unit total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

Code information

Code Number VFEM020-R; Lot Number 59691447; Serial Number 16704032017-01

Distribution pattern

US distribution to AZ, CA, FL, OH, PA, TX, VA, WV

device · product 8 of 15

Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resterilized.

Z-3034-2018
Recall number
Z-3034-2018
Initiated
March 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
SPS Sterilization, Inc
Quantity
1 unit total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

Code information

Code Number OPTI22-R; Lot Number 59637295; Serial Number 16502032017-01

Distribution pattern

US distribution to AZ, CA, FL, OH, PA, TX, VA, WV

device · product 9 of 15

Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 12MM X 90MM | 75CM L, resterilized.

Z-3035-2018
Recall number
Z-3035-2018
Initiated
March 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
SPS Sterilization, Inc
Quantity
2 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

Code information

Code Number 40213-R; Lot Number 18030192; Serial Number 21408032017-10, 21408032017-11

Distribution pattern

US distribution to AZ, CA, FL, OH, PA, TX, VA, WV

device · product 10 of 15

Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 22MM X 45MM | 75CM L, resterilized.

Z-3036-2018
Recall number
Z-3036-2018
Initiated
March 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
SPS Sterilization, Inc
Quantity
2 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

Code information

Code Number 40451-R; Lot Number 18098774; Serial Number 21408032017-12, 21408032017-13

Distribution pattern

US distribution to AZ, CA, FL, OH, PA, TX, VA, WV

device · product 11 of 15

Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 24MM X 70MM | 75CM L, resterilized.

Z-3037-2018
Recall number
Z-3037-2018
Initiated
March 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
SPS Sterilization, Inc
Quantity
2 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

Code information

Code Number 40512-R; Lot Number 17984215; Serial Number 21408032017-14, 21408032017-15

Distribution pattern

US distribution to AZ, CA, FL, OH, PA, TX, VA, WV

device · product 12 of 15

Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, resterilized.

Z-3038-2018
Recall number
Z-3038-2018
Initiated
March 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
SPS Sterilization, Inc
Quantity
2 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

Code information

Code Number 6559-R; Lot Number 17252887 (Serial Number 16211282016-02); Lot Number 17465176 (Serial Numbers 97403172017-16, 97403172017-40)

Distribution pattern

US distribution to AZ, CA, FL, OH, PA, TX, VA, WV

device · product 13 of 15

Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 8MM X 80MM | 75CM, resterilized.

Z-3039-2018
Recall number
Z-3039-2018
Initiated
March 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
SPS Sterilization, Inc
Quantity
2 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

Code information

Code Number 71130-R; Lot Number 17401915; Serial Number 21408032017-01, 21408032017-02

Distribution pattern

US distribution to AZ, CA, FL, OH, PA, TX, VA, WV

device · product 14 of 15

Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Self-Expanding Stent, 10MM X 94MM | 135CM, resterilized.

Z-3040-2018
Recall number
Z-3040-2018
Initiated
March 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
SPS Sterilization, Inc
Quantity
3 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

Code information

Code Number 71139-R; Lot Numbers 17752073, 17752073, 17422520; Serial Numbers 21408032017-03, 21408032017-04, 21408032017-05

Distribution pattern

US distribution to AZ, CA, FL, OH, PA, TX, VA, WV

device · product 15 of 15

Vascular Solutions Venture Rx Catheter, 6F, resterilized.

Z-3041-2018
Recall number
Z-3041-2018
Initiated
March 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
SPS Sterilization, Inc
Quantity
3 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

Code information

Code Number 5820-R; Lot Number 570183 (Serial Number 99804132016-07); Lot Number 583022 (Serial Number 17304202017-07, 17304202017-08)

Distribution pattern

US distribution to AZ, CA, FL, OH, PA, TX, VA, WV