Hazard

Loss Of Sterility recalls

333 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 333
Critical: 26
Severe: 45
Most recent: 2026-08-12

Of the 333 loss of sterility recalls we have scored against our rubric, 26 (8%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 45 (14%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all loss of sterility recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

76–100 of 333

HighFDA (Devices)·Z-2105-2017·2017-05-24
Medline Recalls 10 mm Distraction Pins Due to Sterile Seal Concerns
Medline Industries is recalling 10 mm Distraction Pins because the sterile packaging seal may be compromised, potentially causing the device to lose sterility.
Product
10 mm Distraction Pin, Aggressive Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fix
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2107-2017·2017-05-24
Medline 12 mm Distraction Pin Recalled for Potential Sterility Loss
Medline Industries is recalling 300 packs of 12 mm Distraction Pins because the sterile packaging seal may be compromised, potentially allowing the device to lose sterility.
Product
12 mm Distraction Pin, Blunt Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2104-2017·2017-05-24
Medline Recalls Distraction Pins Due to Potential Sterility Loss
Medline Industries is recalling 2,112 packs of sterile distraction pins because the packaging seal may be compromised, risking loss of sterility.
Product
16 mm [or 18 mm] Distraction Pin, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fix
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2056-2017·2017-05-17
Zimmer Biomet Recalls Cobalt Bone Cement Due to Packaging Seal Issues
Zimmer Biomet is recalling specific lots of Cobalt bone cement because a breach in the sterile Tyvek packaging could lead to loss of sterility.
Product
Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1901-2017·2017-05-10
Breg Inc Recalls Sterile Dressings Due to Unsealed Pouches
Breg Inc is recalling sterile dressings (P/N 02328) because a small percentage may have unsealed pouches, rendering them non-sterile.
Product
Dressing Knee/Shldr, P/N 02328 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be app
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1908-2017·2017-05-10
Breg Recalls If Hip Sterile Polar Dressings Due to Unsealed Pouches
Breg Inc is recalling 2,609 units of If Hip Sterile Polar Dressings because some may have unsealed pouches, rendering them non-sterile.
Product
If Hip, Sterile Polar Dressing P/N 10680 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1906-2017·2017-05-10
Breg Inc Recalls Unsealed Sterile Dressings for Cold Therapy Pads
Breg Inc is recalling approximately 2,609 sterile dressings used with cold therapy pads because some may have unsealed pouches, rendering them non-sterile.
Product
Dressing Shldr XL, P/N 04918 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be appli
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1905-2017·2017-05-10
Breg Inc Recalls Sterile Dressings Due to Potential Unsealed Pouches
Breg Inc is recalling approximately 2,609 sterile dressings because a small percentage may have unsealed pouches, rendering them non-sterile.
Product
Dressing Shldr, P/N 04908 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1902-2017·2017-05-10
Breg Inc Recalls Sterile Dressings Due to Unsealed Pouches
Breg Inc is recalling 2,609 sterile dressings because approximately 0.22% may have unsealed pouches, rendering them non-sterile.
Product
Dressing M/U XL, P/N 02344 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0206-2017·2016-12-28
Baxter Recalls Fluconazole Injection Bags Due to Sterility Concerns
Baxter Healthcare is recalling 30,910 bags of Fluconazole Injection due to confirmed customer complaints of leaking bags, which compromises sterility.
Product
FLUCONAZOLE — FLUCONAZOLE (FLUCONAZOLE)
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0096-2017·2016-10-19
Hospira Recalls Marcaine Injection Due to Sterility and Potency Issues
Hospira is recalling 15 vials of Marcaine 0.25% injection because a glass defect allowed water to enter, compromising sterility and reducing drug potency.
Product
MARCAINE — MARCAINE (BUPIVACAINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2761-2016·2016-09-14
Riverpoint Medical Recalls Nylon Surgical Sutures Due to Seal Integrity Issues
Riverpoint Medical is recalling sterile nylon surgical sutures because the seals may become open during distribution or packaging.
Product
Nylon Surgical Suture for human use and vet use, sold under brand name Riverlon, Securolon, Weblon. Product is sterile. Part numbers: 663BK 663BL 664BL 928BK Product Usage: For use in general soft tissue approximation and/or ligation, including use in cardiovascular, oph
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2733-2016·2016-09-14
Integra Cranial Access Kits Recalled Due to Potential Sterility Compromise
Integra LifeSciences is recalling Cranial Access Kits because product seals may open during distribution, rendering the devices unsterile.
Product
Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2762-2016·2016-09-14
Riverpoint Medical Recalls Webglo Polypropylene Surgical Sutures Due to Seal Issues
Riverpoint Medical is recalling specific lots of Webglo polypropylene surgical sutures because the seals may open during distribution or packaging.
Product
Polypropylene Surgical Sutures, brand Webglo, for vet use. Product is sterile. Part number: GP8665 Product Usage: For use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0861-2016·2016-06-01
Baxter Recalls Sodium Chloride Injection Bags Due to Sterility Concerns
Baxter Healthcare is recalling 282,080 bags of 0.9% Sodium Chloride Injection USP due to a lack of assurance of sterility caused by potential container leaks.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0156-2016·2015-10-28
Smith & Nephew MOSAICPLASTY Harvesting System Recalled for Packaging Breach
Smith & Nephew is recalling MOSAICPLASTY DP- Disposable Harvesting Systems because a breach in the packaging compromised the device's sterility.
Product
Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile Part Number: 7209235 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2800-2015·2015-09-30
Zien Medical PenBlade Safety Scalpel Recalled for Sterile Barrier Risk
Zien Medical Technologies is recalling PenBlade Safety Scalpels because cracks in the PET trays may compromise the sterile barrier.
Product
PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters up to 6Fr. Models PB-M-10, PB-M-11P, PB-M-15
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2762-2015·2015-09-23
Revmedx Recalls XGAUZE Trauma Dressings Due to Potential Package Integrity Issues
Revmedx Inc is recalling XGAUZE Trauma Dressings because shipping containers may have caused small tears or pinholes in the packaging, potentially rendering the sterile devices unsterile.
Product
XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual compressed cellulose sponges. Upon contact with blood or exudate, the sponges expand, thus increasing the dressing's capacity to absorb fluids.
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-0504-2015·2014-12-10
Teleflex Medical Recalls Aquapak Nebulizer Adaptors Due to Sterility Concerns
Teleflex Medical is recalling Aquapak Nebulizer Adaptors because packaging seals may be open or weak, potentially compromising the sterility of the devices.
Product
Aquapak Adaptor, 028 NEB, INTL, Product No. 403128; Aquapak Adaptor, 033 NEB, INTL, Product No. 403133; Aqaupak Nebulizer Adaptor 028, Sterile, Shelfpak, Product No. 031-28 & 031-28F, Aqaupak Nebulizer Adaptor 033, Sterile, Shelfpak, Product No. 031-33; Aqaupak Nebulizer Adaptor
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0280-2015·2014-12-03
Hospira Recalls IV Bags Due to Potential Sterility Breach
Hospira is recalling 823,296 bags of 5% Dextrose and 0.45% Sodium Chloride Injection due to potential punctures that may compromise sterility.
Product
5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-09.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0279-2015·2014-12-03
Hospira Recalls 5% Dextrose Injection Bags Due to Sterility Concerns
Hospira is recalling 301,560 bags of 5% Dextrose Injection due to potential punctures that may compromise sterility and cause leaks.
Product
5% Dextrose Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7922-09.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2670-2014·2014-10-01
Centurion Medical Products Recalls Saline Flush Syringes Due to Open Seals
Centurion Medical Products is recalling 21,388 saline flush syringes used in convenience kits because open seals may compromise package integrity and sterility.
Product
0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe 10 mL REF#306553 used in Centurion Convenience Kits. Recalled product is attached to the outside of the Convenience Kits.
Category
Medical Device
Distribution
20 states
CriticalFDA (Devices)·Z-2446-2014·2014-09-10
Customed Recalls Central Line Full Body Drapes Due to Packaging Integrity Concerns
Customed, Inc. is recalling Central Line Full Body Drapes because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
CENTRAL LINE FULL BODY DRAPE CUSTOMED CONTENTS: (1) WRAPPER 30" X 30" (2) MASK SURGICAL W/ VISOR ANTI-FOG 160mm Hg (2) CAP NURSE 21" GREEN BOUFFANT (2) TOWELS ABSORBENT 15" X 20" (2) GOWN LARGE STANDARD SMS VELCRO/NECK (1) DRAPE SHEET 41" X 58" SMS (1) DRAPE BRACHIAL AN
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2356-2014·2014-09-10
Customed Recalls Arthroscopy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 273 units of arthroscopy packs across 11 lots because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
ARTHROSCOPY PACK- (2) ABSORBENT TOWELS 15" x 20" LIF (1) TUBE SUCTION CONNECT Y.." X 12' LIF (1) ELASTIC BANDAGE 6" X 5yrd. UF (1) IMPERVIOUS STOCKINETTE 14" X 48" (1) HUCK CLOTH TOWEL WHITE (1) MAYO STAND COVER REINFORCED LIF (1) U DRAPE 60" X70" WITH TAPE SPLIT (4) STR
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2533-2014·2014-09-10
Customed Recalls Laparoscopy Colorectal Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 280 units of Laparoscopy Colorectal Surgical Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
LAPAROSCOPY COLORECTAL SURGICAL PACK code 900-2259A, contains: (1) SOLUTION SURGICAL DURAPREP 26ml LIF (4) DRAPE UTILITY WITH TAPE LIF (3) TOWELS ABSORBENT 15" X 20" LIF (2) LEGGINS W/7'' CUFF 30" X 42" LIF (1) BLADE SURGICAL# 15 STAINLESS STEEL (1) BLADE SURGICAL# 11 STA
Category
Medical Device
Distribution
Distributed nationwide